General Information

Extina foam contains 2% ketoconazole USP, an antifungal agent.
The mechanism of action of ketoconazole in the treatment of
seborrheic dermatitis is not known.

Extina is specifically indicated for the treatment of seborrheic
dermatitis in immunocompetent patients 12 years of age and
older.

Extina is supplied as a foam designed for topical
administration. The recommended initial dose of the drug is
application to the affected area(s) twice daily for four weeks.

Clinical Results

FDA Approval
FDA approval of Extina was based on the results of a randomized,
double-blind, vehicle-controlled study. This trial enrolled 847
subjects 12 years and older with mild to severe seborrheic
dermatitis. Subjects received Extina foam or vehicle foam applied
twice daily for 4 weeks to affected areas on the face, scalp,
and/or chest. Overall disease severity, including erythema,
scaling, and induration were assessed at baseline and week 4 on a
5-point Investigator’s Static Global Assessment (ISGA) scale.
Treatment success was defined as achieving a Week 4 ISGA score of 0
(clear) or 1 (mild or faint) and at least two grades of improvement
from baseline. Treatment success was reached in 56% of the subjects
receiving Extina compared to 42% on vehicle foam.

Side Effects

Adverse events associated with the use of Extina may include,
but are not limited to, the following:

Application site burning

Application site reactions including:

Dryness

Erythema

Irritation

Paresthesia

Pruritus

Rash

Warmth

Mechanism of Action

Extina foam contains 2% ketoconazole USP, an antifungal agent.
The mechanism of action of ketoconazole in the treatment of
seborrheic dermatitis is not known. Ketoconazole inhibits the in
vitro synthesis of ergosterol, a key sterol in the cell membrane of
Malassezia furfur.